SK already knows if Sunrise trial will be successful. IMO, SK is so confident, and is so willing to indulge the go-it-alone scenario, because he already has a pretty good idea of how Phase III Sunrise patients are doing from comparing enrollment numbers with overall number of Bavi doses shipped.
Here’s how SK knows so much. The Ph III protocol provides for Sunrise patients to continue dosing with Bavi for as long as they have not progressed. ClinicalTrial.gov says " Patients who have not experienced disease progression will continue to receive Bavituximab weekly until progression." The control group patients don’t get those extra doses of Bavi. Thus there is an easy way for SK and Shan to determine roughly how many Bavi arm patients are still progression-free. If Avid has been producing and shipping much more Bavi to the 150 clinics than just the amount needed to get half the enrolled patients through the Bavi dosing required by the official protocol, then Mgmt has a pretty good idea of how well the Bavi arm of the trial is doing.
I welcome comments on this hypothesis. The only road block I can see would be if PPHM has to stockpile in advance with the Sunrise CRO a much larger amount of Bavi than is actually needed for the initial protocol dosing of the 300 Bavi patients and never learns how much of that extra inventory has been used. But such a surplus dosing requirement would seem to very unfair for the FDA to impose. It would add a huge extra cost burden on the Company with very limited value in terms of safeguarding secrecy of trial results. After all, SK can’t tell whether an extra 200 units of Sunrise Bavi dosing are being divided as 2 units for each of 100 Bavi patients or 4 units for each of 50 patients. It could be just 20 Bavi patients who have each survived unusually long and received 10 extra dosing units each.
Thus I conclude that the extra units of Bavi dosing that the Company has sent to the Sunrise CRO give SK a very good generalized idea of how well the Bavi arm of the trial is doing. Remember, the protocol requires that: " Patients who have not experienced disease progression will continue to receive Bavituximab weekly until progression."
If SK does indeed have this positive Sunrise indicator in his pocket, it’s no wonder that he is taking his time to strike the perfect BP deal. If he knows from the large amount of extra dosing he has shipped that TTP is way out there, then this would mean that OS is way out there as well. Depending on how much extra Bavi has been shipped, SK and Shan could estimate the maximum no. of death events in the Bavi arm and how likely Accelerated Approval might be at the 2nd look-in in the fall of 2015. If SK has this ace in his pocket, why wouldn’t he play hard to get with BP.
